Indian pharma companies are expected to benefit from improving demand in the US market, said India Ratings and Research (Ind-Ra).
As per the rating agency, these companies have garnered 45 percent of all new Abbreviated New Drug Application (ANDA) approvals over the past nine months.
Besides, Ind-Ra expects the regulatory environment to remain stringent.
However, it said well-equipped companies would be able to take the advantage of a better pricing outlook emanating from supply shortages and recalls.
“Indian companies have received a higher share of new ANDA approvals since April 2020 led by significant manufacturing facility clearances, GDUFA-II (Generic Drug User Fee Amendments), and a strong filing momentum aided by historical investments in R&D,” Ind-Ra added in a report.
“Ind-Ra has seen an increasing drug demand since the start of the Covid-19 pandemic led by supply chain issues, channel filling, and demand for Covid-19 led preventive products. In the past, too, there was a drug shortage in the US due to the exit of the large generic players from unviable products.”
“Overall drug shortages in the US are leading to moderate-to-stable pricing pressures.”
Furthermore, it cited that majority of the drug recalls (91 percent) from the US markets are from the non or least serious category (Class-II and III recall).
Accordingly, only ‘Class-I’ drug recalls are serious in nature.